Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01303796 | A Study of Oral Sapacitabine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia | PHASE3 | COMPLETED | 482 | — | — | Oct 1, 2011 | Jul 31, 2017 | Jun 22, 2022 | 118 | United States, Austria +10 |
| NCT00590187 | Efficacy Study of Oral Sapacitabine to Treat Acute Myeloid Leukemia in Elderly Patients | PHASE2 | COMPLETED | 105 | — | — | Dec 1, 2007 | Dec 1, 2018 | Jun 4, 2024 | 15 | United States |
The distribution of overall survival was estimated by the method of Kaplan and Meier. A log-rank analysis stratified by randomization stratification factors was used to compare overall survival between Arm A (decitabine/sapacitabine) versus Arm C (decitabine). Cox proportional hazards models were used to identify predictive factors for overall survival.
Percentage of patients alive for one year measured from the date of randomization
| Arm | Type | Description |
|---|---|---|
| Sapacitabine-decitabine alternating | EXPERIMENTAL | Arm A sapacitabine administered in alternating cycles with decitabine |
| Decitabine | ACTIVE_COMPARATOR | Arm C Decitabine |
| A sapacitabine | EXPERIMENTAL | 200 mg b.i.d. x 7 days every 3-4 weeks |
| B sapacitabine | EXPERIMENTAL | 300 mg b.i.d. x 7 days every 3 - 4 weeks |
| C sapacitabine | EXPERIMENTAL | 400 mg b.i.d. x 3 days/week x 2 weeks every 3 - 4 weeks |
| D sapacitabine | EXPERIMENTAL | 200 mg b.i.d. x 7 consecutive days every 4 weeks |
| E sapacitabine | EXPERIMENTAL | 300 mg q.d. x 7 consecutive days every 4 weeks |
| F sapacitabine | EXPERIMENTAL | 300 mg b.i.d. x 3 consecutive days per week for 2 weeks every 4 weeks |
| G sapacitabine | EXPERIMENTAL | 200 mg b.i.d. x 7 consecutive days every 4 weeks |
| H sapacitabine | EXPERIMENTAL | 300 mg q.d. x 7 consecutive days every 4 weeks |
| I sapacitabine | EXPERIMENTAL | 100 mg q.d. x 5 consecutive days per week for 2 weeks every 4 weeks |
| Name | Type | Description |
|---|---|---|
| Sapacitabine | DRUG | Oral sapacitabine capsules |
| Decitabine | DRUG | Decitabine intravenous |
| Sapacitabine, Arm A | DRUG | 200 mg b.i.d. x 7 days every 3-4 weeks |
| Sapacitabine, Arm B | DRUG | 300 mg b.i.d. x 7 days every 3 - 4 weeks |
| Sapacitabine, Arm C | DRUG | 400 mg b.i.d. x 3 days/week x 2 weeks every 3 - 4 weeks |
| Sapacitabine, Arm D | DRUG | 200 mg b.i.d. x 7 consecutive days every 4 weeks |
| sapacitabine, Arm E | DRUG | 300 mg q.d. x 7 consecutive days every 4 weeks |
| sapacitabine, Arm F | DRUG | 300 mg b.i.d. x 3 consecutive days per week for 2 weeks every 4 weeks |
| Sapacitabine, Arm G | DRUG | 200 mg b.i.d. x 7 consecutive days every 4 weeks |
| Sapacitabine, Arm H | DRUG | 300 mg q.d. x 7 consecutive days every 4 weeks |
| Sapacitabine, Arm I | DRUG | 100 mg q.d. x 5 consecutive days per week for 2 weeks every 4 weeks |
Inclusion Criteria: * Newly diagnosed AML based on WHO (World Health Organization) classification * Age 70 years or older for whom the treatment of choice is low-intensity therapy by investigator assessment or who has refused intensive induction therapy recommended by investigator * ECOG (Eastern C...